Cellectar Biosciences, Inc. 10-K

Item 8. Financial Statements. FINANCIAL STATEMENTS INDEX TO FINANCIAL STATEMENTS FOR CELLECTAR BIOSCIENCES, INC. Page Report of Independent Registered Public Accounting Firm ( Deloitte & Touche LLP , Morristown, New Jersey , PCAOB ID No. 34 ) 61 Consolidated Balance Sheets as of December 31, 2024 and 2023 63 Consolidated Statements of Operations for the Years Ended December 31, 2024 and 2023 64 Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the Years Ended December 31, 2024 and 2023 65 Consolidated Statements of Cash Flows for the Years Ended December 31, 2024 and 2023 66 Notes to Consolidated Financial Statements 67 ​ ​ 60 Table of Contents REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the shareholders and the Board of Directors of Cellectar Biosciences, Inc. Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of Cellectar Biosciences, Inc. and subsidiaries (the “Company”) as of December 31, 2024 and 2023, the related consolidated statements of operations, statements of convertible preferred stock and stockholders’ equity (deficit), and cash flows, for each of the two years in the period ended December 31, 2024, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America. Going Concern The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has incurred significant losses and negative cash flows from operations and has limited capital resources to fund its ongoing operations that raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. Basis for Opinion These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion. Critical Audit Matter The critical audit matter communicated below is a matter arising from the current-period audit of the financial statements that was communicated or required to be communicated to the audit committee and that (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates. 61 Table of Contents Initial Accounting for the Warrant Exercise Inducement Transaction — Refer to “Note 6. Stockholders’ Equity” to the financial statements Critical Audit Matter Description On July 21, 2024, the Company, entered into a warrant exercise inducement (the “Inducement”) with certain holders of its September 2023 Tranche B warrants, pursuant to which the holders agreed to exercise the warrants to purchase 1,610 shares of the Company’s Series E-4 Convertible Voting Preferred Stock (the “Series E-4 preferred stock”) which were convertible to 6,739,919 shares of the Company’s common stock in the aggregate, at a reduced, as-converted common stock price of $2.52 per share, in exchange for the Company’s issuance of new warrants (the “Inducement Warrants”), with varying termination dates and exercise prices. The Company received gross proceeds of $19.4 million and net proceeds of $17.5 million. As included in Note 6 to the financial statements, the Inducement Warrants were comprised of three separate tranches, each with a unique exercise price contractual term. Due to a cash settlement feature included in the Inducement Warrants that requires cash settlement in the event of a fundamental transaction that is outside the Company’s control resulting in a form of settlement inconsistent with that which would be received by other security holders, the warrants do not qualify under the equity classification guidance. As a result, and in accordance with the guidance in ASC 815, the Inducement Warrants issued in July 2024 were deemed to be liabilities and are adjusted to fair value each reporting period. We identified the assessment of the initial accounting for the warrant exercise inducement transaction as a critical audit matter because of the complexity in applying the accounting framework and the significant judgments made by management in the determination of the classification and valuation of the Inducement Warrants. This required a high degree of auditor judgment and an increased extent of effort when performing audit procedures to evaluate the reasonableness of management’s classification, as well as the valuation of the Inducement Warrants. How the Critical Audit Matter Was Addressed in the Audit Our audit procedures related to the classification and valuation of the Inducement Warrants included the following, among others: ● We read the agreements associated with the Inducement Warrants and tested the accuracy and completeness of the significant terms identified by management for the purpose of determining the appropriate accounting treatment and classification of the Inducement Warrants. ● With the assistance of professionals in our firm having expertise in the accounting treatment for financial instruments, we evaluated the Company’s conclusions regarding the accounting treatment applied to the Inducement Warrants. ● With the assistance of our fair value specialists, we evaluated management’s valuation of the Inducement Warrants by: o Evaluating management’s use of the Monte Carlo simulation methodology o Testing the significant valuation assumptions, including the expected volatility, the risk-free interest rate, expected life and dividend yield o Independently calculating a fair value estimate for the Inducement Warrants and comparing our estimates to management’s estimates /s/ Deloitte & Touche LLP Morristown, New Jersey March 12, 2025 We have served as the Company’s auditor since 2024. ​ 62 Table of Contents CELLECTAR BIOSCIENCES, INC. CONSOLIDATED BALANCE SHEETS ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ December 31, ​ 2024 2023 ASSETS ​ ​ CURRENT ASSETS: ​ ​ Cash and cash equivalents ​ $ 23,288,607 ​ $ 9,564,988 Prepaid expenses and other current assets ​ 961,665 ​ 888,225 Total current assets ​ 24,250,272 ​ 10,453,213 Property, plant & equipment, net ​ 757,121 ​ 1,090,304 Operating lease right-of-use asset ​ 436,874 ​ 502,283 Other long-term assets ​ 29,780 ​ 29,780 TOTAL ASSETS ​ $ 25,474,047 ​ $ 12,075,580 ​ ​ ​ ​ ​ ​ ​ LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY ​ ​ ​ ​ CURRENT LIABILITIES: ​ ​ ​ ​ Accounts payable and accrued liabilities ​ $ 7,585,340 ​ $ 9,178,645 Warrant liability ​ ​ 1,718,000 ​ ​ 16,120,898 Lease liability, current ​ ​ 84,417 ​ ​ 58,979 Total current liabilities ​ 9,387,757 ​ ​ 25,358,522 Lease liability, net of current portion ​ ​ 409,586 ​ ​ 494,003 TOTAL LIABILITIES ​ 9,797,343 ​ ​ 25,852,525 COMMITMENTS AND CONTINGENCIES (Note 10) ​ ​ MEZZANINE EQUITY: ​ ​ Series D convertible preferred stock, 111.11 shares authorized; 111.11 shares issued and outstanding as of December 31, 2024 and 2023 ​ 1,382,023 ​ ​ 1,382,023 STOCKHOLDERS’ (DEFICIT) EQUITY: ​ ​ ​ ​ ​ ​ Series E-2 preferred stock, 1,225.00 shares authorized; 35.60 and 319.76 shares issued and outstanding as of December 31, 2024 and 2023, respectively ​ ​ 520,778 ​ ​ 4,677,632 Common stock, $ 0.00001 par value; 170,000,000 shares authorized; 46,079,875 and 20,744,110 shares issued and outstanding as of December 31, 2024 and 2023, respectively ​ 461 ​ ​ 207 Additional paid-in capital ​ 261,115,905 ​ ​ 182,924,210 Accumulated deficit ​ ( 247,342,463 ) ​ ​ ( 202,761,017 ) Total stockholders’ (deficit) equity ​ 14,294,681 ​ ​ ( 15,158,968 ) TOTAL LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY ​ $ 25,474,047 ​ $ 12,075,580 ​ See accompanying notes to the consolidated financial statements. ​ ​ 63 Table of Contents CELLECTAR BIOSCIENCES, INC. CONSOLIDATED STATEMENTS OF OPERATIONS ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ 2024 2023 ​ ​ ​ ​ ​ ​ ​ OPERATING EXPENSES: ​ ​ Research and development ​ $ 26,136,246 ​ $ 27,266,276 General and administrative ​ 25,641,452 ​ 11,694,367 Total operating expenses ​ 51,777,698 ​ ​ 38,960,643 ​ ​ ​ ​ ​ ​ ​ LOSS FROM OPERATIONS ​ ( 51,777,698 ) ​ ​ ( 38,960,643 ) ​ ​ ​ ​ ​ ​ ​ OTHER INCOME (EXPENSE): ​ ​ ​ ​ Warrant issuance expense ​ ( 7,743,284 ) ​ ​ ( 470,000 ) Gain (loss) on valuation of warrants ​ ​ 13,794,683 ​ ​ ( 3,787,114 ) Interest income ​ 1,210,853 ​ ​ 387,147 Total other income (expense), net ​ 7,262,252 ​ ​ ( 3,869,967 ) LOSS BEFORE INCOME TAXES ​ ​ ( 44,515,446 ) ​ ​ ( 42,830,610 ) ​ ​ ​ ​ ​ ​ ​ INCOME TAX PROVISION (BENEFIT) ​ ​ 66,000 ​ ​ ( 60,000 ) ​ ​ ​ ​ ​ ​ ​ NET LOSS ​ $ ( 44,581,446 ) ​ $ ( 42,770,610 ) NET LOSS PER SHARE — BASIC ​ $ ( 1.22 ) ​ $ ( 3.50 ) NET LOSS PER SHARE — DILUTED ​ $ ( 1.40 ) ​ $ ( 3.50 ) WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING — BASIC ​ ​ 36,622,474 ​ ​ 12,221,571 WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING — DILUTED ​ 37,143,769 ​ ​ 12,221,571 ​ See accompanying notes to the consolidated financial statements. ​ ​ 64 Table of Contents CELLECTAR BIOSCIENCES, INC. CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Series D Preferred Stock ​ ​ Preferred Stock ​ Common Stock ​ Additional Paid-In ​ Accumulated ​ Total Stockholders’ ​ Shares Amount Shares Amount Shares Par Amount Capital Deficit Equity (Deficit) Balance at December 31, 2022 111.11 ​ $ 1,382,023 ​ ​ — ​ ​ — ​ 9,385,272 ​ $ 94 ​ $ 168,143,557 ​ $ ( 159,990,407 ) ​ $ 8,153,244 Stock-based compensation — ​ ​ — ​ ​ — ​ ​ — ​ — ​ ​ — ​ ​ 2,410,288 ​ ​ — ​ ​ 2,410,288 Exercise of warrants for common stock — ​ ​ — ​ ​ — ​ ​ — ​ 1,197,622 ​ ​ 12 ​ ​ 2,467,210 ​ ​ — ​ ​ 2,467,222 Issuance of Series E-2 preferred stock, net of issuance costs ​ — ​ ​ — ​ ​ 1,225.00 ​ ​ 17,820,000 ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ 17,820,000 Conversion of preferred stock to common stock — ​ — ​ ( 905.24 ) ​ ( 13,142,368 ) 9,947,684 ​ 99 ​ 13,142,269 ​ — ​ — Reclassification of pre-funded warrants to liability — ​ — ​ — ​ — — ​ — ​ ( 3,239,112 ) ​ — ​ ( 3,239,112 ) Stock awards — ​ ​ — ​ ​ — ​ ​ — ​ 213,532 ​ ​ 2 ​ ​ ( 2 ) ​ ​ — ​ ​ — Net loss — ​ ​ — ​ ​ — ​ ​ — ​ — ​ ​ — ​ ​ — ​ ​ ( 42,770,610 ) ​ ​ ( 42,770,610 ) Balance at December 31, 2023 111.11 ​ ​ 1,382,023 ​ ​ 319.76 ​ $ 4,677,632 ​ 20,744,110 ​ $ 207 ​ $ 182,924,210 ​ $ ( 202,761,017 ) ​ $ ( 15,158,968 ) Stock-based compensation — ​ ​ — ​ ​ — ​ ​ — ​ — ​ ​ — ​ ​ 4,272,780 ​ ​ — ​ ​ 4,272,780 Exercise of pre-funded warrants into common shares — ​ ​ — ​ ​ — ​ ​ — ​ 1,079,132 ​ ​ 11 ​ ​ 3,972,529 ​ ​ — ​ ​ 3,972,540 Exercise of warrants for preferred stock, net of issuance costs (Note 2) — ​ ​ — ​ ​ 2,205.00 ​ ​ 47,577,000 ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ 47,577,000 Conversion of Series E-3 preferred stock into common stock ​ — ​ ​ — ​ ​ ( 2,205.00 ) ​ ​ ( 47,577,000 ) ​ 13,846,141 ​ ​ 139 ​ ​ 47,576,861 ​ ​ — ​ ​ — Exercise of warrants for common stock — ​ ​ — ​ ​ — ​ ​ — ​ 547,177 ​ ​ 5 ​ ​ 2,298,138 ​ ​ — ​ ​ 2,298,143 Conversion of Series E-2 preferred stock into common stock ​ — ​ ​ — ​ ​ ( 284.00 ) ​ ​ ( 4,156,854 ) ​ 3,122,637 ​ ​ 31 ​ ​ 4,156,823 ​ ​ — ​ ​ — Issuance of E-4 preferred stock net of issuance costs ​ — ​ ​ — ​ ​ 1,610.00 ​ ​ 15,914,632 ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ 15,914,632 Conversion of Series E-4 preferred stock into common stock ​ — ​ ​ — ​ ​ ( 1,610.00 ) ​ ​ ( 15,914,632 ) ​ 6,739,919 ​ ​ 68 ​ ​ 15,914,564 ​ ​ — ​ ​ — Stock option exercise into common stock — ​ ​ — ​ ​ — ​ ​ — ​ 767 ​ ​ — ​ ​ — ​ ​ — ​ ​ — Retired shares — ​ — ​ — ​ — ( 8 ) ​ — ​ — ​ — ​ — Net loss — ​ ​ — ​ ​ — ​ ​ — ​ — ​ ​ — ​ ​ — ​ ​ ( 44,581,446 ) ​ ​ ( 44,581,446 ) Balance at December 31, 2024 111.11 ​ $ 1,382,023 ​ ​ 35.60 ​ $ 520,778 ​ 46,079,875 ​ $ 461 ​ $ 261,115,905 ​ $ ( 247,342,463 ) ​ $ 14,294,681 ​ See accompanying notes to the consolidated financial statements. ​ ​ 65 Table of Contents CELLECTAR BIOSCIENCES, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, ​ 2024 2023 ​ ​ ​ ​ ​ ​ ​ CASH FLOWS FROM OPERATING ACTIVITIES: ​ ​ Net loss ​ $ ( 44,581,446 ) ​ $ ( 42,770,610 ) Adjustments to reconcile net loss to cash used in operating activities: ​ ​ ​ ​ ​ Depreciation and amortization ​ 291,653 ​ ​ 192,375 Stock-based compensation ​ 4,272,780 ​ ​ 2,410,288 Loss on disposal of assets ​ ​ 145,726 ​ ​ — Warrant issuance expense ​ ​ 7,743,284 ​ ​ 470,000 Change in fair value of warrants ​ ​ ( 13,794,683 ) ​ ​ 3,787,114 Change in operating lease right-of-use asset ​ 65,409 ​ ​ 58,051 Changes in: ​ ​ ​ ​ ​ Prepaid expenses and other assets ​ ​ ( 73,440 ) ​ ​ ( 173,548 ) Accounts payable and accrued liabilities ​ ( 1,593,305 ) ​ ​ 3,700,202 Lease liability ​ ​ ( 58,979 ) ​ ​ ( 50,846 ) Cash used in operating activities ​ ( 47,583,001 ) ​ ​ ( 32,376,974 ) CASH FLOWS FROM INVESTING ACTIVITIES: ​ ​ Purchases of property, plant & equipment ​ ( 104,195 ) ​ ​ ( 864,038 ) Cash used in investing activities ​ ( 104,195 ) ​ ​ ( 864,038 ) CASH FLOWS FROM FINANCING ACTIVITIES: ​ ​ Proceeds from issuance of stock and warrants, net of issuance costs ​ — ​ ​ 22,150,000 Proceeds from exercise of warrants ​ 61,410,815 ​ ​ 789,642 Cash provided by financing activities ​ 61,410,815 ​ ​ 22,939,642 INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS ​ 13,723,619 ​ ​ ( 10,301,370 ) CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD ​ 9,564,988 ​ ​ 19,866,358 CASH AND CASH EQUIVALENTS AT END OF PERIOD ​ $ 23,288,607 ​ $ 9,564,988 SUPPLEMENTAL DISCLOSURE OF NON-CASH INFORMATION ​ ​ ​ ​ ​ Conversion of preferred stock to common stock ​ $ 67,648,487 ​ $ 13,242,368 Settlement of warrants to equity ​ $ 12,608,199 ​ $ 3,239,112 ​ See accompanying notes to the consolidated financial statements. ​ 66 Table of Contents CELLECTAR BIOSCIENCES, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 1. NATURE OF BUSINESS AND ORGANIZATION Cellectar Biosciences, Inc. (Cellectar or the Company) is a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, leveraging our proprietary phospholipid drug conjugate™ (PDC™) delivery platform that specifically targets cancer cells and delivers improved efficacy and better safety as a result of fewer off-target effects. Going Concern — As an emerging growth company, the Company has, by design, incurred significant recurring losses and used net cash in its operations since its inception as it devotes substantially all of its efforts towards researching, developing and seeking approval for its product candidates to be commercialized in the marketplace. As a result of these efforts, the Company had an accumulated deficit of approximately $ 247,342,000 as of December 31, 2024, and incurred a net loss of approximately $ 44,581,000 during the year ended December 31, 2024. The Company expects it will continue to generate significant losses and use net cash for the foreseeable future, until such time that one or more of its product candidates are approved and successfully commercialized in the marketplace. While management believes one or more of the Company’s product candidates will be approved and successfully commercialized in the marketplace, no assurance can be provided any products will be approved or commercialized in a profitable manner. To fund its research, development, and approval efforts, the Company has been heavily dependent on funding from private investors and public stockholders since its inception through the issuance of securities, such as common stock, convertible preferred stock, and warrants (collectively referred to as outside capital). The Company expects to remain heavily dependent on outside capital to fund the Company’s operations for the foreseeable future until such time that one or more of its product candidates are approved and successfully commercialized in the marketplace. While management believes additional outside capital will be secured as needed, no assurance can be provided that additional outside capital will be secured or secured on terms that are acceptable to the Company. As of the date the accompanying consolidated financial statements were issued (the “issuance date”), the Company’s available liquidity to fund the Company’s operations over the next twelve months beyond the issuance date was limited to approximately $ 14.9 million of unrestricted cash and cash equivalents. Absent further action taken by management to increase its liquidity the Company may be unable to fund its operations under normal course beyond the fourth quarter of 2025. To improve the Company’s liquidity, management plans to secure additional outside capital via the sale of equity and/or debt securities or execute a strategic transaction. Management also plans to preserve liquidity, as needed, by implementing temporary cost saving measures. While management believes their plans will be successful, no assurance can be provided such plans will be effectively implemented over the next twelve months beyond the issuance date. In the event management’s plans are not effectively implemented, the Company will be required to seek other alternatives which may include, among others, the sale of assets, discontinuance of certain operations, a wind-down of operations and return of capital to stockholders, and/or filing for bankruptcy protection. These uncertainties raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying financial statements have been prepared on the basis that the Company will continue to operate as a going concern, which contemplates it will be able to realize assets and settle liabilities and commitments in the normal course of business for the foreseeable future. Accordingly, the accompanying consolidated financial statements do not include any adjustments that may result from the outcome of these uncertainties. 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES The accompanying consolidated financial statements reflect the application of certain accounting policies, as described in this note and elsewhere in the notes to the consolidated financial statements. Principles of Consolidation — The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. All inter-company accounts and transactions have been eliminated in consolidation. The Company consists of one reportable segment. Use of Estimates — The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and judgments that may affect the reported amounts of assets, liabilities and expenses and disclosure of contingent assets and liabilities. On an on-going basis, management evaluates its estimates including those related to 67 Table of Contents potential accrued liabilities, valuation of warrant and equity-based instruments, and share-based compensation. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from those estimates under different assumptions or conditions. Changes in estimates are reflected in reported results in the period in which they become known. Cash and Cash Equivalents — All short-term investments purchased with original maturities of three months or less are considered to be cash equivalents. Property, Plant & Equipment — Property, plant & equipment are stated at cost. Depreciation on property and equipment is provided using the straight-line method over the estimated useful lives of the assets ( 3 to 10 years ). Leasehold improvements are depreciated over 64 months (their estimated useful life), which represented the full term of the lease at the time the leasehold improvements were capitalized. Our only long-lived assets are property, equipment and Right-of-Use (ROU) assets. The Company periodically, and at a minimum annually, evaluates long-lived assets for potential impairment. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds the fair value of the asset. Such analyses necessarily involve judgement. The Company recorded disposal charges of approximately $ 146,000 and $ 0 during the years ended December 31, 2024 and 2023, respectively. Right-of-Use Asset and Lease Liability — The Company accounts for all material leases in accordance with FASB Accounting Standards Codification (ASC) Topic 842, Leases . ROU assets are recognized over their estimated useful life, which represents the full term of the lease. See Note 11. Stock-Based Compensation — The Company uses the Black-Scholes option-pricing model to calculate the grant-date fair value of stock option awards. The resulting compensation expense, net of expected forfeitures, for awards that are not performance-based, is recognized on a straight-line basis over the service period of the award, which for 2024 and 2023 ranged from twelve months to three years . Research and Development — Research and development costs are expensed as incurred. The Company recognizes cost reimbursements from government grants when it is probable that the Company will comply with the conditions attached to the grant arrangement and the grant proceeds will be received. Government grants are recognized on a systematic basis over the periods in which the Company recognizes the related costs for which the government grant is intended to compensate. Specifically, when government grants are related to reimbursements for operating expenses, the government grants are recognized as a reduction of the related expense. Income Taxes — Income taxes are accounted for using the liability method of accounting. Under this method, deferred tax assets and liabilities are determined based on temporary differences between the financial statement basis and tax basis of assets and liabilities and net operating loss and credit carryforwards using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when it is more-likely-than-not that some portion of the deferred tax assets will not be realized. Management has provided a full valuation allowance against the Company’s net deferred tax asset. Tax positions taken or expected to be taken in the course of preparing tax returns are required to be evaluated to determine whether the tax positions are more-likely-than-not to be sustained by the applicable tax authority. Tax positions deemed to not meet a more-likely-than-not threshold would be recorded as tax expense in the current year. There were no uncertain tax positions that require accrual to or disclosure in the consolidated financial statements as of December 31, 2024 and 2023. Fair Value of Financial Instruments The guidance under FASB ASC Topic 825, Financial Instruments , requires disclosure of the fair value of certain financial instruments. Financial instruments in the accompanying consolidated financial statements consist of cash equivalents, prepaid expenses and other assets, accounts payable, accrued liabilities, warrant liabilities and long-term obligations. The carrying amount of cash equivalents, prepaid expenses, other current assets, accounts payable and accrued liabilities approximate their fair value as a result of their short-term nature. See Note 3 . Warrants — The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in ASC 480, Distinguishing Liabilities from Equity (“ASC 480”) and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding 68 Table of Contents financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own common stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding. For equity-classified warrants, the fair value is not remeasured. For warrants that are liability-classified, changes in fair value, as well as the cost to issue the warrants, are included in Other Income (Expense) in the accompanying Consolidated Statements of Operations. If these instruments are initially classified as either liabilities or equity and a subsequent assessment determines that the classification has changed, the Company reflects that change in the financial statements. Preferred Stock — The Company accounts for preferred stock based upon their specific terms and the authoritative guidance in ASC 480 and ASC 815, including whether they are freestanding instruments, whether any redemption or conversion aspects exist and how they are required to be settled (for example, if there are features that may require cash settlement), contain characteristics that are predominantly debt-like or equity-like, have embedded derivatives, and if they have redemption features. Based upon analysis of these criteria, the preferred stock will be classified as either debt, temporary (or “mezzanine”) equity, or permanent equity. The resultant classification is then evaluated quarterly to determine whether any change to the classification is required. Concentration of Credit Risk — Financial instruments that subject the Company to credit risk consist of cash and cash equivalents on deposit with financial institutions. The Company’s excess cash as of December 31, 2024 and 2023, is on deposit in interest-bearing accounts with well-established financial institutions. At times, such amounts may exceed the Federal Deposit Insurance Corporation (FDIC) insurance limits. As of December 31, 2024 and 2023, uninsured cash balances totaled approximately $ 22,837,000 and $ 9,123,000 , respectively. Government Assistance — For the fiscal year beginning January 1, 2022, management adopted ASU 2021-10, Government Assistance (Topic 832), which aims to provide increased transparency by requiring business entities to disclose information about certain types of government assistance they receive in the notes to the financial statements. Reimbursements of eligible expenditures pursuant to government assistance programs are recorded as reductions of operating costs when there is reasonable assurance that the Company will comply with the conditions attached to the grant arrangement and when the reimbursement has been claimed. The determination of the amount of the claim, and accordingly the receivable amount, requires management to make calculations based on its interpretation of eligible expenditures in accordance with the terms of the programs. The reimbursement claims submitted by the Company are subject to review by the relevant government agencies . The Company currently has a cancer treatment research award through the National Cancer Institute (NCI) totaling approximately $ 2.0 million over a period of approximately three years. In September 2022, the Company was awarded $ 1.98 million in additional grant funding to expand the Company’s ongoing Phase 1 study of iopofosine I 131 in children and adolescents with inoperable relapsed or refractory high-grade gliomas (HGGs). The grant was awarded by the NCI based upon the initial signals of efficacy in the Phase 1 study, which is an international, open-label, dose escalation, safety study. The funding allows for an expansion from Part 1a into the Part 1b portion of the ongoing Phase 1 pediatric study. During the twelve months ended December 31, 2024, the Company received approximately $ 602,000 in NCI grant funding under the grants described above, all of which was reported as a reduction of research and development (R&D) expenses. During the twelve months ended December 31, 2023, the Company received approximately $ 1,759,000 in NCI grant funding under the grants described above, all of which was reported as a reduction of research and development (R&D) expenses. Recently Issued Accounting Pronouncements Not Yet Adopted — In December 2023, the FASB issued Accounting Standards Update (ASU) No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which is intended to enhance the transparency and decision usefulness of income tax disclosures. Public business entities are required to adopt this standard for annual fiscal periods beginning after December 15, 2024, and early adoption is permitted. The Company is evaluating the impact the adoption of this guidance will have on its consolidated financial statements and related disclosures. In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. The amendments in ASU 2024-03 address investor requests for more detailed expense information and require additional disaggregated disclosures in the notes to financial statements for certain categories of expenses that are included on the face of the income statement. This guidance is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with 69 Table of Contents early adoption permitted. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements. The Company evaluates all ASUs issued by the FASB for consideration of their applicability to the financial statements. The Company has assessed all ASUs issued but not yet adopted and concluded that those not disclosed are not relevant to the Company or are not expected to have a material impact. Recently Adopted Accounting Pronouncements — In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280). The amendments in this update expand segment disclosure requirements, including new segment disclosure requirements for entities with a single reportable segment among other disclosure requirements. The Company adopted this ASU retrospectively. See Note 13. 3. FAIR VALUE In accordance with Fair Value Measurements and Disclosures Topic of the FASB ASC 820, the Company groups its financial assets and financial liabilities generally measured at fair value in three levels, based on the markets in which the assets and liabilities are traded, and the reliability of the assumptions used to determine fair value: ● Level 1: Input prices quoted in an active market for identical financial assets or liabilities. ● Level 2: Inputs other than prices quoted in Level 1, such as prices quoted for similar financial assets and liabilities in active markets, prices for identical assets, and liabilities in markets that are not active or other inputs that are observable or can be corroborated by observable market data. ● Level 3: Input prices quoted that are significant to the fair value of the financial assets or liabilities which are not observable or supported by an active market. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The carrying value of cash and cash equivalents approximates fair value as maturities are less than three months. The carrying amounts reported for other current financial assets and liabilities approximate fair value because of their short-term nature. The Company evaluates its financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level in which to classify them for each reporting period, pursuant to the policy described in Note 2. This determination requires significant judgments be made. The following table summarizes the conclusions reached as of December 31, 2024 and 2023 for financial instruments measured at fair value on a recurring basis. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Balance Level 1 Level 2 Level 3 December 31, 2024 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Cash and cash equivalents ​ $ 23,288,607 ​ $ 23,288,607 ​ $ — ​ $ — Total assets ​ $ 23,288,607 ​ $ 23,288,607 ​ $ — ​ $ — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Warrant liability ​ $ 1,718,000 ​ $ — ​ $ — ​ $ 1,718,000 Total liabilities ​ $ 1,718,000 ​ $ — ​ $ — ​ $ 1,718,000 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2023 ​ ​ ​ ​ ​ ​ ​ ​ Cash and cash equivalents ​ $ 9,564,988 ​ $ 9,564,988 ​ $ — ​ $ — Total assets ​ $ 9,564,988 ​ $ 9,564,988 ​ $ — ​ $ — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Warrant liability ​ $ 16,120,898 ​ $ — ​ $ 2,989,207 ​ $ 13,131,691 Total liabilities ​ $ 16,120,898 ​ $ — ​ $ 2,989,207 ​ $ 13,131,691 ​ 70 Table of Contents July 2024 Warrants As part of the July 2024 inducement financing the Company issued Tranche A, B, and C warrants (the Inducement Warrants) to purchase shares of common stock (see Note 2). The fair value of the Inducement Warrants was determined using a probability-weighted expected return method (PWERM) with a scenario-based Monte Carlo simulation and Black-Scholes model. The PWERM is a scenario-based methodology that estimates the fair value of the Company’s different classes of equity based upon an analysis of future values for the Company, assuming various outcomes. Under both models, assumptions and estimates are used to value the warrants. The Company assesses these assumptions and estimates on a quarterly basis as additional information that impacts the assumptions is obtained. The quantitative elements associated with the inputs impacting the fair value measurement of the Inducement Warrants include the value per share of the underlying common stock, the timing, form and overall value of the expected exits for the stockholders, the risk-free interest rate, the expected dividend yield and the expected volatility of the Company’s shares. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve for time periods approximately equal to the remaining contractual term of the warrants. The Company estimated a 0 % dividend yield based on the expected dividend yield and the fact that the Company has never paid or declared cash dividends. Expected volatility was determined based upon the historical volatility of the Company’s common stock. The Inducement Warrants are classified within the Level 3 hierarchy because of the nature of these inputs and the valuation technique utilized, and had a fair value of $ 12,000,000 and $ 1,200,000 as of July 21, 2024, the date of issuance, and December 31, 2024, respectively, which is included in the warrant liability caption on the accompanying balance sheets. The following table summarizes the modified option-pricing assumptions used on December 31, 2024, and July 21, 2024: ​ ​ ​ ​ ​ ​ ​ ​ December 31, July 21, ​ ​ 2024 ​ 2024 Volatility 80.6 - 104.0 % 75.9 - 82.0 % Risk-free interest rate 3.50 - 4.20 % 4.10 - 4.20 % Expected life (years) 0.5 - 4.8 0.7 - 5.0 ​ Dividend 0 % 0 % ​ September 2023 Warrants As part of the September 2023 financing the Company issued Tranche A and Tranche B warrants (the 2023 Warrants) to purchase shares of preferred stock which, on an as-converted basis, represented an aggregate of 21,025,641 shares of common stock. The fair value of the Tranche A and B warrants was determined using a probability-weighted expected return method (PWERM) with a scenario-based Monte Carlo simulation and Black-Scholes model. The PWERM is a scenario-based methodology that estimates the fair value of the Company’s different classes of equity based upon an analysis of future values for the Company, assuming various outcomes. Under both models, assumptions and estimates are used to value the preferred stock warrants. The Company assesses these assumptions and estimates on a quarterly basis as additional information that impacts the assumptions is obtained. The quantitative elements associated with the inputs impacting the fair value measurement of the 2023 Warrants include the value per share of the underlying common stock, the timing, form and overall value of the expected exits for the stockholders, the risk-free interest rate, the expected dividend yield and the expected volatility of the Company’s shares. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve for time periods approximately equal to the remaining contractual term of the warrants. The Company estimated a 0 % dividend yield based on the expected dividend yield and the fact that the Company has never paid or declared cash dividends. Expected volatility was determined based upon the historical volatility of the Company’s common stock. As previously described, all of the Tranche A warrants were exercised in January 2024. Additionally, in July 2024, the holders of the Tranche B warrants exercised all but 105.00 of the Tranche B warrants outstanding. As a result, those warrants were marked-to-market on July 21, 2024, the date of the exercise and subsequent settlement. The 2023 Warrants are classified within the Level 3 hierarchy because of the nature of these inputs and the valuation technique utilized, and had a fair value of $ 26,000 and $ 4,200,000 as of December 31, 2024 and December 31, 2023, respectively, which is included in the warrant liability caption on the accompanying balance sheets. They continue to be classified as a liability due to a cash settlement feature in the agreement. 71 Table of Contents The following table summarizes the modified option-pricing assumptions used on December 31, 2024 and December 31, 2023: ​ ​ ​ ​ ​ ​ ​ ​ December 31, December 31, ​ ​ 2024 ​ 2023 ​ Volatility 105 % 82.0 - 83.0 % Risk-free interest rate 4.2 - 4.3 % 3.80 - 5.40 % Expected life (years) 0.8 - 4.2 0.3 - 4.7 ​ Dividend 0 % 0 % ​ At the time the Tranche A warrants were exercised, their fair value, calculated as the difference between the common stock conversion rate in the Series E-3 preferred stock and the trading price of the stock when the warrants were exercised, was determined to be $ 4,800,000 . At the time the Tranche B warrants were exercised, their fair value, calculated as the difference between the common stock conversion rate in the Series E-4 preferred stock, as adjusted by the inducement offering terms, and the trading price of the stock when the warrants were exercised, was determined to be $ 2,610,000 . Due to the settlement of these warrants, the corresponding liability was reclassified to equity in accordance with ASC 815. October 2022 Warrants In October 2022 the Company issued a total of 5,151,098 common warrants that are immediately exercisable with a five-year life and a strike price of $ 1.96 for shares of common stock (the 2022 Common Warrants), and 1,875,941 pre-funded warrants (the 2022 Pre-Funded Warrants) to acquire shares of common stock (see Note 6). The 2022 Pre-Funded Warrants were all exercised prior to December 31, 2024. The fair value of the 2022 Common Warrants was determined by utilizing a Black-Scholes option-pricing model. The quantitative elements associated with the inputs impacting the fair value measurement of the 2022 Common Warrants include the value per share of the underlying common stock, the risk-free interest rate, the expected dividend yield and the expected volatility of the Company’s shares. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve for time periods approximately equal to the remaining contractual term of the warrants. The Company estimated a 0 % dividend yield based on the expected dividend yield and the fact that the Company has never paid or declared cash dividends. Expected volatility was determined based upon the historical volatility of the Company’s common stock. These warrants are classified within the Level 3 hierarchy because of the nature of these inputs and the valuation technique utilized. The following table summarizes the assumptions used at each financial reporting date: ​ ​ ​ ​ ​ ​ ​ ​ December 31, December 31, ​ ​ 2024 ​ 2023 ​ Volatility 117.5 % 81.1 % Risk-free interest rate 4.27 % 3.84 % Expected life (years) 2.8 3.8 ​ Dividend 0 % 0 % ​ The following table summarizes the changes in the fair market value of the warrants which are classified within the Level 3 fair value hierarchy, inclusive of all Preferred and Common Warrants, excluding the Pre-Funded Common Warrants: ​ ​ ​ ​ ​ ​ Level 3 Fair value of Level 3 liabilities as of December 31, 2023 ​ $ 13,131,691 Change in warrant fair value ​ ​ ( 14,778,015 ) Issuance of July 2024 Inducement Warrants ​ ​ 12,000,000 Settlement of 2023 Tranche A Warrants to equity ​ ​ ( 4,800,000 ) Settlement of 2023 Tranche B Warrants to equity ​ ​ ( 2,610,000 ) Exercise of October 2022 Warrants ​ ​ ( 1,225,676 ) December 31, 2024, fair value of Level 3 liabilities ​ $ 1,718,000 ​ ​ 72 Table of Contents 4. PROPERTY, PLANT & EQUIPMENT Property, plant & equipment consisted of the following as of December 31: ​ ​ ​ ​ ​ ​ ​ ​ ​ 2024 2023 ​ ​ ​ ​ ​ ​ ​ Office and laboratory equipment ​ $ 1,467,000 ​ $ 1,661,000 Computer software ​ 4,000 ​ ​ 4,000 Leasehold improvements ​ 310,000 ​ ​ 310,000 Total property, plant & equipment ​ 1,781,000 ​ ​ 1,975,000 Less– accumulated depreciation and amortization ​ ( 1,024,000 ) ​ ​ ( 885,000 ) Property, plant & equipment, net ​ $ 757,000 ​ $ 1,090,000 ​ For the years ended December 31, 2024 and 2023, the Company recorded approximately $ 292,000 and $ 192,000 of fixed asset depreciation and amortization expense, respectively. 5. ACCOUNTS PAYABLE AND ACCRUED LIABILITIES Accounts payable and accrued liabilities consist of the following as of December 31: ​ ​ ​ ​ ​ ​ ​ ​ ​ 2024 2023 ​ ​ ​ ​ ​ ​ ​ Accounts payable $ 4,105,000 ​ $ 5,620,000 Incentive compensation ​ ​ 611,000 ​ ​ 2,069,000 Clinical project costs ​ ​ 1,339,000 ​ ​ 1,252,000 Professional fees ​ ​ 219,000 ​ ​ 153,000 Other ​ ​ 1,311,000 ​ ​ 85,000 ​ $ 7,585,000 ​ $ 9,179,000 ​ 6. STOCKHOLDERS’ EQUITY July 2024 Warrant Inducement On July 21, 2024, the Company, entered into a warrant exercise inducement (the “Inducement”) with certain holders of its September 2023 Tranche B warrants, pursuant to which the holders agreed to exercise the warrants to purchase 1,610 shares of the Company’s Series E-4 Convertible Voting Preferred Stock, par value $ 0.00001 per share (the “Series E-4 preferred stock”) which were convertible to 6,739,919 shares of the Company’s common stock in the aggregate, at a reduced, as-converted common stock price of $ 2.52 per share, in exchange for the Company’s issuance of new warrants (the “Inducement Warrants”), with varying termination dates and exercise prices. The Company received gross proceeds of $ 19.4 million and net proceeds of $ 17.5 million. The Inducement Warrants have the following terms: ● The 2024 Tranche A warrants have an exercise price of $ 2.52 and expire at the earlier of (i) ten (10) trading days following the date of the Company’s public announcement that the FDA has assigned a Prescription Drug User Fee Act goal date for review of iopofosine I 131, and (ii) July 21, 2029. ● The 2024 Tranche B warrants have an exercise price of $ 4.00 and expire at the earlier of (i) ten (10) trading days following the date of the Company’s public announcement of its receipt of written approval from the FDA of its New Drug Application for iopofosine I 131, and (ii) July 21, 2029. ● The 2024 Tranche C warrants have an exercise price of $ 5.50 and expire at the earlier of (i) ten (10) trading days following the date of the Company’s public announcement that it has recorded quarterly gross revenues from sales of iopofosine I 131 in the United States in excess of $ 10 million and (ii) July 21, 2029. 73 Table of Contents Due to a cash settlement feature that requires cash settlement in the event of a fundamental transaction that is outside the Company’s control resulting in a form of settlement inconsistent with that which would be received by other security holders, the warrants do not qualify under the equity classification guidance. As a result, and in accordance with the guidance in ASC 815, the warrants issued in July 2024 are deemed to be liabilities. All such liabilities are required to be presented at fair value, with changes reflected in financial results for the period. See Note 3 for the related valuation. In accordance with the guidance above, the Company recorded the Inducement Warrants and preferred stock at their respective fair values. Utilizing valuation techniques described in Note 3, the Company computed the fair value of the Inducement Warrants as $ 12.0 million and recorded the preferred stock at approximately $ 15.9 million, which represented its fair value of $ 17.0 million less allocated issuance costs. The value of the preferred stock and Inducement Warrants sold exceeded the proceeds received by the Company and the fair value of the Tranche B warrants that were exercised in the transaction, which was approximately $ 2.6 million at the time of exercise. The value in excess of the net proceeds and the fair value of the Tranche B warrants of approximately $ 7.7 million is reflected in Other Expense. As of December 31, 2024, all of the Series E-4 preferred stock issued in the July 2024 financing has been converted into 6,739,919 shares of common stock. September 2023 Private Placement On September 8, 2023, in a private placement with certain institutional investors, the Company issued 1,225 shares of Series E-1 preferred stock, along with Tranche A warrants to purchase 2,205 shares of Series E-3 preferred stock and Tranche B warrants to purchase 1,715 shares of Series E-4 preferred stock. Shares of Series E preferred stock were issued at a fixed price of $ 20,000 per share, resulting in gross proceeds of $ 24.5 million and net proceeds of approximately $ 22.2 million after placement agent fees and other customary expenses. The conversion prices for the preferred stock are as follows: for the Series E-1 or E-2 preferred stock, $ 1.82 per share of common stock, or a total of 13,461,538 shares of common stock; for the Series E-3 preferred stock, $ 3.185 per share of common stock, or a total of 13,846,154 shares of common stock; and for the Series E-4 preferred stock, $ 4.7775 per share of common stock, or a total of 7,179,487 shares of common stock, in each case subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization. The warrants were exercisable as follows: ● Tranche A warrants, for an aggregate exercise price of $ 44.1 million, exercisable for Series E-3 preferred stock until the earlier of September 6, 2026, or 10 trading days after the Company’s announcement of positive topline data from the Waldenstrom’s macroglobulinemia CLOVER WaM pivotal trial; and, ● Tranche B warrants, for an aggregate exercise price of $ 34.3 million, exercisable for Series E-4 preferred stock until the earlier of September 6, 2028, or 10 days following the Company’s public announcement of its receipt of written approval from the FDA of its New Drug Application for iopofosine I 131. As of December 31, 2023, the Tranche A and Tranche B warrants did not qualify as derivatives; however, they did not meet the requirements necessary to be considered indexable in the Company’s stock. As a result, and in accordance with the guidance in FASB ASC 815, the warrants were deemed to be liabilities. As of September 30, 2024, the Tranche B warrants do not qualify as derivatives and meet the requirements necessary to be considered indexable in the Company’s stock. However, due to a cash settlement feature that requires cash settlement in event of a fundamental transaction that is outside the Company’s control resulting in a form of settlement inconsistent with that which would be received by other security holders, the warrants do not qualify under the equity classification guidance. As a result, and in accordance with the guidance in ASC 815, the Tranche B warrants continue to be deemed liabilities. All such liabilities are required to be presented at fair value, with changes reflected in financial results for the period. As discussed above, the majority of the Tranche B warrants were exercised in July 2024. See Note 3 for the related valuation. When issued, the Series E-1 preferred stock had a redemption feature; therefore, it was classified as mezzanine equity as of September 30, 2023. The Series E-1 preferred stock also had a liquidation preference, which was calculated as an amount per share equal to the greater of (i) two times (2X) the Original Per Share Price, together with any declared, unpaid dividends, or (ii) such amount per share as would have been payable had all shares of Series E-1 preferred stock been converted into Common Stock immediately prior to such Liquidation. While the Series E - 1 preferred was outstanding, this resulted in both the Tranche A and Tranche B warrants being considered puttable by virtue of the liquidation preference impacting the disposition of these warrants in the 74 Table of Contents event of a liquidation. In accordance with the guidance in ASC 480, a puttable warrant is deemed to be a liability. These features only applied to the Series E-1 preferred stock when it was outstanding; upon stockholder approval of the transaction, which was obtained by the Company at a special meeting of stockholders held on October 25, 2023, the Series E-1 preferred stock immediately converted into either Series E-2 preferred stock and/or common stock, dependent upon the beneficial ownership position of the holder. The net proceeds from the September 2023 Private Placement were allocated first to the fair value of the Tranche A and Tranche B warrants, which had a fair value upon issuance of $ 4,800,000 , with the remainder, or $ 17,820,000 , allocated to the Series E-1 preferred stock. Upon stockholder approval of the transaction, the entire amount that had been assigned to mezzanine equity was reclassified to Series E-2 preferred stock and is a component of permanent equity, as is reflected in the financial statements. As a result of the stockholder approval, Series E-1 preferred stock was fully extinguished in accordance with the terms of the financing. The outstanding shares of Series E preferred stock were classified as permanent equity upon issuance. Series E preferred stock is convertible to common stock at the request of the holder, subject to the holder not exceeding certain beneficial ownership percentages as stipulated in the financing agreement. Subsequent to the issuance of the Series E-2 preferred stock and prior to December 31, 2023, preferred holders converted 905.24 shares of preferred stock into 9,947,684 shares of common stock at the stated rate of $ 1.82 per common share, resulting in 319.76 shares of Series E - 2 preferred stock outstanding as of December 31, 2023. During the twelve months ended December 31, 2024, 284.16 shares of Series E-2 preferred stock were converted into 3,122,637 shares of common stock. There remain 35.60 shares of Series E-2 preferred stock outstanding as of December 31, 2024. In January 2024, the Company released topline data from its pivotal, Phase 2b CLOVER WaM trial. In accordance with the terms of the Tranche A warrant, the warrants’ expiration accelerated to 10 trading days after the topline data release. Warrant holders exercised the Tranche A warrants in their entirety, resulting in the Company issuing 2,205.00 shares of Series E-3 preferred stock, which were convertible to common stock at the stated rate of $ 3.185 per share, and receiving gross proceeds of $ 44.1 million and net proceeds of $ 42.8 million (see Note 3). As of December 31, 2024, all of the Series E-3 preferred stock has been converted into 13,846,141 shares of common stock. October 2022 Public Offering and Private Placement On October 25, 2022, the Company completed a registered direct offering of 3,275,153 shares of the Company’s common stock at $ 2.085 per share and warrants to purchase up to an aggregate of 3,275,153 shares of common stock in a concurrent private placement priced at-the-market under Nasdaq rules. In a separate concurrent private placement transaction, the Company offered and sold pre-funded warrants to purchase an aggregate of 1,875,945 shares of common stock and warrants to purchase an aggregate of 1,875,945 shares of common stock. The warrants are immediately exercisable at an exercise price of $ 1.96 per share and will expire on the fifth anniversary of the closing date. Each pre-funded warrant had a purchase price of $ 2.08499 , is immediately exercisable at an exercise price of $ 0.00001 per share and will not expire until exercised in full. The registered direct offering and private placements resulted in total gross proceeds of approximately $ 10.7 million with net proceeds to the Company of approximately $ 9.6 million after deducting estimated offering expenses. During the twelve months ended December 31, 2024, 1,079,132 pre-funded warrants, which was the entirety of the quantity still outstanding, were converted into 1,079,132 shares of common stock, and 547,177 warrants issued in October 2022 were exercised for net proceeds of approximately $ 1.1 million. There were no such conversions or exercises in the twelve months ended December 31, 2023. 75 Table of Contents Warrants The following table summarizes information with regard to outstanding warrants to purchase stock as of December 31, 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Number of Common ​ ​ ​ ​ ​ ​ ​ Shares Issuable ​ ​ ​ ​ ​ ​ ​ Upon ​ ​ ​ ​ ​ ​ ​ Exercise of ​ ​ ​ ​ ​ ​ ​ Outstanding ​ Exercise ​ ​ Offering Warrants Price Expiration Date 2024 Tranche A Warrants ​ 6,739,918 ​ $ 2.52 ​ July 21, 2029 2024 Tranche B Warrants ​ 8,214,278 ​ $ 4.00 ​ July 21, 2029 2024 Tranche C Warrants 4,267,152 ​ $ 5.50 ​ July 21, 2029 2023 Tranche B Preferred Warrants 439,560 ​ $ 4.7775 ​ September 8, 2028 2022 Common Warrants ​ 4,201,044 ​ $ 1.96 ​ October 25, 2027 June 2020 Series H Common Warrants ​ 720,796 ​ $ 12.075 ​ June 5, 2025 Total 24,582,748 ​ ​ ​ ​ All warrants in the table above are liability-classified. ​ 7. STOCK-BASED COMPENSATION Accounting for Stock-Based Compensation 2021 Stock Incentive Plan The Company maintains the 2021 Stock Incentive Plan (the “2021 Plan”). The Company utilizes stock-based compensation incentives as a component of its employee and non-employee director and officer compensation philosophy. A committee of the Board of Directors determines the terms of the awards granted and may grant various forms of equity-based incentive compensation. Currently, these incentives consist principally of stock options and restricted shares. All outstanding awards under the 2015 Stock Incentive Plan (the “2015 Plan”) remained in effect according to the terms of the 2015 Plan. Any shares that are currently available under the 2015 Plan and any shares underlying 2015 Plan awards which are forfeited, cancelled, reacquired by the Company or otherwise terminated are added to the shares available for grant under the 2021 Plan. Under the current stock option award program, all options become exercisable between one and three years after issuance and expire after ten years. The fair value of each stock option award is estimated on the grant date using the Black-Scholes option-pricing model. Volatility is based on the Company’s historical common stock volatility. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time. The expected term of stock options granted is based on an estimate of when options will be exercised in the future. Forfeitures are recorded as they occur. No dividends have been recorded historically. At the annual meeting of stockholders held on June 14, 2024, the Company’s stockholders approved an increase in the number of shares of common stock available for issuance under the 2021 Stock Incentive Plan by 7,000,000 to 9,368,900 . During the twelve months ended December 31, 2024 and 2023, stock options granted were 3,063,500 and 1,617,000 , respectively. The following table summarizes amounts charged to expense for stock-based compensation related to employee and director stock option grants: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Twelve Months Ended ​ ​ December 31, ​ 2024 2023 Employee and director stock option and stock grants: ​ ​ ​ ​ Research and development ​ $ 3,486,168 ​ $ 505,155 General and administrative ​ 786,612 ​ ​ 1,905,133 Total stock-based compensation ​ $ 4,272,780 ​ $ 2,410,288 ​ 76 Table of Contents In December 2023, the Company granted 2,776,000 contingent, non-statutory stock option awards at an exercise price of $ 2.63 per share to employees and directors, and in March 2024 the Company granted 200,000 contingent, non-statutory stock option awards at an exercise price of $ 3.63 and $ 3.35 per share to our employees. Each of these grants was contingent on approval of an increase in the shares available in the 2021 Stock Incentive Plan that was approved by the stockholders at the annual meeting of stockholders held on June 14, 2024. In accordance with the removal of the contingency, the Company began recognizing the expense for these awards in June 2024. Assumptions Used in Determining Fair Value Valuation and amortization method . The fair value of each stock award is estimated on the grant date using the Black-Scholes option-pricing model. The estimated fair value of employee stock options is amortized to expense using the straight-line method over the required service period which is generally the vesting period. The estimated fair value of the non-employee options is amortized to expense over the period during which a non-employee is required to provide services for the award (usually the vesting period). Volatility. The Company estimates volatility based on the Company’s historical volatility since its common stock has been publicly traded. Risk-free interest rate . The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant commensurate with the expected term assumption. Expected term . The expected term of stock options granted is based on an estimate of when options will be exercised in the future. The Company applied the simplified method of estimating the expected term of the options, as described in the SEC’s Staff Accounting Bulletins 107 and 110, as the historical experience is not indicative of the expected behavior in the future. The expected term, calculated under the simplified method, is applied to groups of stock options that have similar contractual terms. Using this method, the expected term is determined using the average of the vesting period and the contractual life of the stock options granted. The Company applied the simplified method to non-employees who have a truncation of term based on termination of service and utilizes the contractual life of the stock options granted for those non-employee grants which do not have a truncation of service. Forfeitures. The Company only records stock-based compensation expense for those awards that are expected to vest. The Company accounts for forfeitures as they occur. Dividends. The Company has not historically issued dividends. Summary. The following table summarizes the assumptions used for stock options granted to employees and directors in the periods indicated: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ 2024 2023 Volatility ​ 82.13 % ​ 82.02 - 83.28 % Risk-free interest rate ​ 4.21 - 4.64 % ​ 3.59 - 4.68 % Expected life (years) ​ 6.0 ​ 6.0 ​ Dividend ​ 0 % ​ 0 % ​ Exercise prices for all grants made during the twelve months ended December 31, 2024 and 2023 were equal to the market value of the Company’s common stock on the date of grant. ​ 77 Table of Contents Stock Option Activity A summary of stock option activity is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Number of ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Shares ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Issuable ​ ​ ​ ​ Weighted ​ ​ ​ ​ ​ Upon ​ ​ ​ ​ Average ​ ​ ​ ​ ​ Exercise ​ Weighted ​ Remaining ​ ​ ​ ​ ​ of ​ Average ​ Contracted ​ Aggregate ​ Outstanding ​ Exercise Term in ​ Intrinsic ​ Options Price Years Value Outstanding as of December 31, 2022 746,257 ​ $ 13.48 8.58 $ — Granted 1,617,000 ​ $ 1.78 ​ ​ Expired ( 8 ) ​ $ 8,325 ​ ​ Forfeited ( 11,346 ) ​ $ 1.92 ​ ​ Outstanding as of December 31, 2023 ​ 2,351,903 ​ $ 5.46 ​ 8.64 ​ $ 1,682,667 Granted ​ 3,063,500 ​ $ 2.72 ​ ​ ​ ​ ​ Expired ​ ( 1,614 ) ​ $ 20.00 ​ ​ ​ ​ ​ Exercised ​ ( 1,667 ) ​ ​ 1.68 ​ ​ ​ ​ ​ Forfeited ​ ( 825,104 ) ​ $ 2.51 ​ ​ ​ ​ ​ Outstanding as of December 31, 2024 ​ 4,587,018 ​ $ 4.10 ​ 7.37 ​ $ — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Exercisable as of December 31, 2024 2,933,097 ​ $ 3.69 ​ ​ $ — Unvested as of December 31, 2024 1,653,921 ​ $ 2.19 ​ ​ $ — ​ The aggregate intrinsic value of options outstanding is calculated based on the positive difference between the estimated per-share fair value of common stock at the end of the respective period and the exercise price of the underlying options. Shares of common stock issued upon the exercise of options are from authorized but unissued shares. At December 31, 2024, we had 4,746,451 shares available for grant under the 2021 Option Plan. The weighted-average grant-date fair value of options granted during the years ended December 31, 2024 and 2023, was $ 2.45 and $ 1.35 , respectively. The total fair value of shares vested during the years ended December 31, 2024 and 2023, was $ 5,342,685 and $ 1,670,964 , respectively. The weighted-average grant-date fair value of vested and unvested options outstanding at December 31, 2024, was $ 3.69 and $ 2.19 , respectively. The weighted-average grant-date fair value of vested and unvested options outstanding at December 31, 2023, was $ 11.13 and $ 1.81 , respectively. The weighted average grant date fair value of options forfeited during the years ended December 31, 2024 and 2023, was $ 1.77 and $ 1.41 , respectively. The number of options vested during the years ended December 31, 2024 and December 31, 2023, was 2,408,864 and 308,136 , respectively. The number of options unvested at December 31, 2024 and December 31, 2023, was 1,653,921 and 1,837,732 , respectively. As of December 31, 2024, there was approximately $ 3,608,000 of total unrecognized compensation cost related to unvested stock-based compensation arrangements. Of this total amount, the Company expects to recognize approximately $ 2,057,000 , $ 1,547,000 , and $ 4,000 during 2025, 2026 and 2027, respectively. The Company’s expense estimates are based upon the expectation that all unvested options will vest in the future. ​ 78 Table of Contents 8. INCOME TAXES ​ ​ ​ ​ ​ ​ ​ ​ ​ 2024 2023 ​ ​ ​ ​ ​ ​ ​ Tax provision (benefit) ​ ​ ​ ​ ​ Current ​ ​ ​ ​ ​ Federal ​ $ — ​ $ — State ​ ​ 66,000 ​ ​ ( 60,000 ) Total current ​ ​ 66,000 ​ ​ ( 60,000 ) ​ ​ ​ ​ ​ ​ ​ Deferred ​ ​ ​ ​ ​ ​ Federal ​ ​ ( 16,105,508 ) ​ ​ ( 12,233,641 ) State ​ ​ ( 3,457,937 ) ​ ​ ( 2,764,638 ) Total deferred ​ ​ ( 19,563,445 ) ​ ​ ( 14,998,279 ) ​ ​ ​ ​ ​ ​ ​ Change in valuation allowance ​ ​ 19,563,445 ​ ​ 14,998,279 Total ​ $ 66,000 ​ $ ( 60,000 ) ​ Deferred tax assets consisted of the following as of December 31: ​ ​ ​ ​ ​ ​ ​ ​ ​ 2024 2023 ​ ​ ​ ​ ​ ​ ​ Deferred tax assets ​ ​ Federal net operating loss ​ $ 47,908,912 ​ $ 39,914,591 Federal research and development tax credit carryforwards ​ ​ 21,358,973 ​ ​ 15,868,907 State net operating losses and tax credit carryforwards ​ ​ 10,191,364 ​ ​ 7,626,490 Capitalized research and development expenses ​ ​ 22,658,402 ​ ​ 20,203,493 Stock-based compensation expense ​ ​ 5,071,709 ​ ​ 3,710,609 Other ​ ​ 419,067 ​ ​ 754,180 Total deferred tax assets ​ ​ 107,608,426 ​ ​ 88,078,270 ​ ​ ​ ​ ​ ​ ​ Deferred tax liabilities ​ ​ ​ ​ ​ ​ Depreciable assets ​ ​ ( 123,186 ) ​ ​ ( 156,626 ) Total deferred tax liabilities ​ ​ ( 123,186 ) ​ ​ ( 156,626 ) ​ ​ ​ ​ ​ ​ ​ Net deferred tax assets ​ ​ 107,485,240 ​ ​ 87,921,644 Less- valuation allowance ​ ​ ( 107,485,240 ) ​ ​ ( 87,921,644 ) Total deferred tax assets ​ $ — ​ $ — ​ A reconciliation of income taxes computed using the U.S. federal statutory rate to that reflected in operations is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended December 31, ​ 2024 2023 Income tax benefit using U.S. federal statutory rate 21.00 % 21.00 % State income taxes 7.44 % 6.92 % Permanent nondeductible items ( 0.09 ) % ( 0.28 ) % Federal tax credits 12.10 % 9.95 % Change in valuation allowance ( 43.91 ) % ( 35.48 ) % Warrant cost ​ 2.86 % ( 2.11 ) % Other 0.45 % 0.14 % Total ( 0.15 ) % 0.14 % ​ 79 Table of Contents As of December 31, 2024, the Company had federal net operating loss (NOL) carryforwards of approximately $ 109,644,000 generated as of December 31, 2017, and NOL carryforwards of approximately $ 118,494,000 after December 31, 2017. Federal NOLs generated as of December 31, 2017, will expire in 2025 through 2037 , while NOLs generated during 2018 and later will be carried forward indefinitely until utilized. As of December 31, 2024, the Company had state NOL carryforwards of approximately $ 135,680,000 . State NOL carryforwards will expire in 2029 through 2044 . As of December 31, 2024, the Company had federal research and development (R&D) and orphan drug credit carryforwards of approximately $ 21,359,000 which will expire in 2024 through 2043 . As of December 31, 2024, the Company also had state credit carryforwards of approximately $ 826,000 which will expire in 2025 through 2039 . The Company had federal NOLs and R&D credit carryforwards of $ 425,000 and $ 5,000 , respectively, that expired in 2024 . The NOL, R&D and orphan drug credit carryforwards may have, or may become subject to, an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, as well as similar state tax provisions. This could limit the amount of NOLs that the Company can utilize annually to offset future taxable income or tax liabilities. The amount of the annual limitation, if any, will be determined based on the value of the Company immediately prior to an ownership change. Subsequent ownership changes may further affect the limitation in future years. If and when the Company utilizes the NOL carryforwards in a future period, it will perform an analysis to determine the effect, if any, of these loss limitation rules on the NOL carryforward balances. The Company has evaluated the available evidence supporting the realization of its deferred tax assets, including the amount and timing of future taxable income, and has determined that it is more likely than not that its net deferred tax assets will not be realized. As a result of uncertainties surrounding the realization of the deferred tax assets, the Company maintains a full valuation allowance against all of its net deferred tax assets. When the Company determines that it will be able to realize some portion or all of its deferred tax assets, an adjustment to the valuation allowance on its deferred tax assets would have the effect of increasing net income in the period such determination is made. The Company did not have unrecognized tax benefits or accrued interest and penalties at any time during the years ended December 31, 2024 or 2023, and does not anticipate having unrecognized tax benefits over the next twelve months. The Company is subject to audit by the Internal Revenue Service and state taxing authorities for tax periods commencing January 1, 2021, as a result of its NOLs. However, any adjustment related to these periods would be limited to the amount of the NOL generated in the year(s) under examination. ​ 9. NET LOSS PER SHARE Basic net loss per share is computed by dividing net loss attributable to common stockholders by the weighted average number of shares of common stock and pre-funded warrants outstanding during the period. The pre-funded warrants are considered common shares outstanding for the purposes of the basic net loss per share calculation due to the nominal cash consideration and lack of other contingencies for issuance of the underlying common shares. Diluted net loss attributable to common stockholders per share is computed by dividing net loss attributable to common stockholders, as adjusted, by the sum of the weighted average number of shares of common stock and the dilutive potential common stock equivalents then outstanding. Potential common stock equivalents consist of stock options, warrants, and convertible preferred shares. In accordance with ASC Topic 260, Earnings per Share, diluted earnings per share are the amount of earnings for the period available to each share of common stock outstanding during the reporting period and to each share that would have been outstanding assuming the issuance of common shares for all dilutive potential common shares 80 Table of Contents outstanding during the reporting period. In the quarters ended June 30, 2024, and September 30, 2024, the common warrants issued in October 2022 were dilutive. In all other periods presented, all outstanding warrants were antidilutive. ​ ​ ​ ​ ​ Year ended December 31, 2024 ​ Net loss ​ $ ( 44,581,446 ) Dilutive effect of warrant liability ​ ( 7,283,786 ) Net loss allocated to common shares ​ $ ( 51,865,232 ) ​ ​ ​ ​ Weighted average common shares outstanding - basic ​ 36,622,474 Dilutive effect of warrant liability ​ 521,295 Weighted average common shares outstanding - diluted ​ 37,143,769 ​ ​ ​ ​ Net loss per share - diluted ​ $ ( 1.40 ) ​ The following potentially dilutive securities have been excluded from the computation of diluted net loss per share since their inclusion would have been antidilutive: ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ 2024 2023 Warrants 20,381,704 ​ 26,923,243 Stock options 4,587,018 ​ 2,351,903 Convertible preferred shares 502,320 ​ 3,624,957 Total potentially dilutive shares 25,471,042 ​ 32,900,103 ​ 10. COMMITMENTS AND CONTINGENCIES Legal The Company may be involved in legal matters and disputes in the ordinary course of business. We do not anticipate that the outcome of such matters and disputes will materially affect the Company’s financial statements. Workforce Reduction In December 2024, the Company implemented a workforce reduction plan impacting approximately 60 % of employees. The total expense charge related to the plan was approximately $ 1,510,000 . The remaining liability related to the plan as of December 31, 2024 was $ 1,180,000 . ​ 11. LEASES Operating Lease Liability In June 2018, the Company executed an agreement for office space in the Borough of Florham Park, Morris County, New Jersey to be used as its headquarters (HQ Lease). The HQ Lease commenced upon completion of certain improvements in October 2018 and terminates in February 2024 with an option to extend the term of the lease for one additional 60 -month period. On December 30, 2022, the Company entered into an Amended Agreement of Lease, with CAMPUS 100 LLC (the “Landlord”). Under the Amended Lease, which was accounted for as a modification of the initial lease, as the Company will continue to lease 3,983 square feet of rentable area on the second floor of a building located at 100 Campus Drive in Florham Park, New Jersey, for the period commencing on March 1, 2023, and ending on April 30, 2029. The Company also has an option to extend the term of the Amended Lease for one additional 60 -month period. Under the terms of the Amended Lease, the Company’s previously paid security deposit of $ 75,000 was reduced to $ 23,566 and the aggregate rent due over the term of the Amended Lease is approximately $ 918,000 , which will be reduced to approximately $ 893,000 after certain rent abatements. The Company will also be required to pay its proportionate share of certain operating expenses 81 Table of Contents and real estate taxes applicable to the leased premises. After certain rent abatements the rent is approximately $ 11,800 per month for the first year and then escalates thereafter by 2 % per year for the duration of the term. The Company has not entered into any leases with related parties. Discount Rate The Company has determined an appropriate interest rate to be used in evaluating the present value of the Amended Lease liability considering factors such as the Company’s credit rating, borrowing terms offered by the U.S. Small Business Administration, amount of lease payments, quality of collateral and alignment of the borrowing term and lease term. The Company considers 14 % per annum as reasonable to use as the incremental borrowing rate for the purpose of calculating the liability under the Amended Lease. In conjunction with the June 2018 lease, the Company had previously used a 10 % per annum incremental borrowing rate. Maturity Analysis of Short-Term and Operating Leases The following table approximates the dollar maturity of the Company’s undiscounted payments for its short-term leases and operating lease liabilities as of December 31, 2024: ​ ​ ​ ​ ​ Years ending December 31, 2025 ​ $ 146,000 2026 ​ ​ 150,000 2027 ​ ​ 153,000 2028 ​ ​ 155,000 Thereafter ​ ​ 53,000 Total undiscounted lease payments ​ 657,000 Less: Imputed interest ​ ( 163,000 ) Present value of lease liabilities $ 494,000 ​ ​ 12. EMPLOYEE RETIREMENT PLAN The Company maintains a defined contribution plan under Section 401(k) of the Internal Revenue Code that allows eligible employees to contribute a portion of their annual compensation on a pre-tax basis. The Company has not made any matching contributions under this plan. 13. OPERATING SEGMENT The Company has one operating and reportable segment focused on utilizing its PDC platform to develop drugs for the treatment of cancer. The accounting policies of the single operating segment are the same as those of the Company. The chief operating decision maker is the Company’s president and CEO, who manages the Company’s operations on a consolidated basis, assesses performance for the operating segment and decides how to allocate resources based on consolidated operating expenses, which are reported in the consolidated statements of operations. The measure of segment assets is reported on the consolidated balance sheets as total consolidated assets. Expenditures for additions to long-lived assets, which include purchases of property and equipment, are included in total consolidated assets reviewed by management and are reported on the consolidated statements of cash flows. 82 Table of Contents Management uses consolidated cash used in operations and budget-to-actual variances for consolidated net loss to assess the performance of the operating segment and evaluate performance and to allocate resources. The following table presents certain financial data for the Company’s one reportable segment: ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ 2024 2023 Research and development: ​ ​ Phase 2 study in WM ​ $ 7,422,000 ​ $ 12,652,000 Phase 1 study in pediatric tumors ​ 3,040,000 ​ 2,480,000 Manufacturing and related costs ​ 10,582,000 ​ 9,341,000 Pre-clinical projects costs ​ 228,000 ​ 483,000 General research and development costs ​ 4,864,000 ​ 2,310,000 General and administrative ​ 25,641,000 ​ 11,694,000 Other segment items ​ ( 7,196,000 ) ​ 3,811,000 Segment and consolidated net loss ​ $ 44,581,000 ​ $ 42,771,000 ​ Other segment items consist of warrant issuance expense, (gain) loss on valuation of warrants, and interest income. ​ 83 Table of Contents Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. None.